ABSTRACT. Vitamin D is supplemented in individuals with or without risk factors for deficiency, although its effects at specific doses and frequency are controversial. In consequence, we aimed to perform an exhaustive review on the effects of vitamin D supplementation in randomized clinical trials in adult patients, grouped by target system and the evaluation criteria established in the objectives, by searching clinical trials published in the last 5 years in PubMed and EBSCO are included, with the keywords "vitamin D supplementation" AND effect, in English or Spanish, excluding participants <19 years Our initial search yielded 91 results from two databases, of which 71 included studies. A total of 24 articles published a significant effect of vitamin D supplementation. Significant effects were identified in 3 of 4 studies in postmenopausal patients on bone density and/or strengthening of the musculoskeletal system. Other statistically significant effects were observed with supplementation in patients with high body mass index, in glucose control and glycosylated hemoglobin levels. We conclude that randomized clinical trials show significant effects in different organs and systems, the effect on glycemic control is promising, even when overrepresenting specific human groups.
OBJECTIVE:Data from placebo-controlled, randomized clinical trials conducted during the past few years resulted in critical re-evaluation of the overall health benefits of hormone therapy (HT) in women during the menopausal transition and thereafter. These data stimulated vigorous debate among experts and produced several position papers by North American and European authorities providing guidance on the use of HT. It is well known that cultural, geographic and ethnic differences influence the acceptance and risk perception of HT. Therefore, it was considered essential to present a position specifically relevant to Latin American countries. METHODS:A Latin American Expert Panel, convening in Salvador, Bahia, Brazil, obtained consensus on recommendations for HT that incorporated the findings of the most recently published reports. The panelists' opinions were surveyed by means of the Likert scale along five categories ranging from complete agreement to complete disagreement. RESULTS:The Panel presented 13 recommendations and considered three additional issues relevant to HT use. There was consensus that HT during the perimenopause and thereafter is warranted in Latin American women in particular for the management of vasomotor symptoms. HT may also be an option for osteoporosis prevention in women at significant risk, after evaluation of risks/benefits and after consideration of alternative therapies. HT should be individualized and prescribed at the lowest effective dose. CONCLUSIONS:The Panel concluded that HT remains a safe and effective treatment option for peri- and postmenopausal Latin American women.
OBJECTIVE:To provide uniform, objective guidance for physicians and other health care workers in Latin America to enhance compliance with hormone therapy (HT), and to provide a tool for continued medical education and a source for answering clinical questions. METHOD:Literature search using MEDLINE; identification of key relevant publications by a five-member expert committee; creation and validation of a 60-item questionnaire used to survey the opinion of 72 physicians participating in a Latin American symposium, "The Faces of Menopause". RESULTS:On the basis of the validated responses, major points were identified to enhance compliance with HT with specific reference to Latin America, and two algorithms were created to provide practical guidance. CONCLUSION:The present guidelines will facilitate optimal compliance with therapy in Latin American postmenopausal women who opt for HT and for whom HT is indicated.
Objective: The present study was undertaken to assess the impact, effectiveness and safety of a monophasic hormone replacement treatment (HRT) for continuous use with regards to the clinical effects, bleeding patterns and lipid profile of menopausal women in four Latin American countries. Design: Three hundred and six postmenopausal women with natural menopause and uterus present were recruited. This was a multicentre prospective, clinical trial; the participating countries were Brazil (BR), Colombia (CO), Mexico (MX) and Argentina (AR). The study period was 12 months. The HRT regime was formulated in tablets containing 2 mg estradiol E2 and 1 mg norethisterone acetate (NETA); one visit every 3 months was solicited. Methods: HRT was given as one tablet every day without interruption for 1 year. Climacteric complaints, side-effects, reason for discontinuation, bleeding patterns, lipid profile at baseline and 12 months of treatment were documented. Results: There were no significant differences between the four populations on clinical measurements. Thirty-four women discontinued, 13 for bleeding problems. The five most common side-effects were mastalgia, bleeding problems, headache, pelvic pain and nausea. 44.8% of women experienced scanty vaginal bleeding during the first 3 months of therapy. Ninety seven percent of women had amenorrhea at the end of the study in MX, BR and AR, and 100% in CO. Body weight was constant during the study, and no correlation was found between body weight and total days with bleeding. The Kupperman index score was used to evaluate the climacteric complaints, and the score decreased from a mean of 25.4 to 5.1 at 12-months visit. Total cholesterol levels were significantly reduced in BR and CO (P < 0.05) between baseline and the final sample; serum triglycerides remained unchanged, HDL-cholesterol was significantly increased in MX (P < 0.05), and LDL-cholesterol was significantly reduced in CO (P < 0.05). The results of this 1-year study emphasize that a continuous combined HRT regimen with 2 mg E2/1 mg NETA is an attractive alternative for postmenopausal women who are at least 1 year after their menopause and optimally 2 years after their menopause. Although the combination of 2 mg E2 with 1 mg NETA in a continuous combined therapy scheme has been in use in the Nordic countries for over a decade and in Latin America for the last 6 years, there have been no previous published reports on its effectivity in Latin American women. This publication reports the experience in a group of 306 Latin American women, and it is the first Latin American publication with this formulation.
OBJECTIVE:To analyze and validate a clinical index (CI) in postmenopausal women that will help to determine the need for bone absorptiometry. METHODS:1088 postmenopausal women were studied; age, body mass index (BMI) and time since menopause (TM) were analyzed. A score was attributed to each variable (0 points if it did not increase the risk of osteoporosis or 1 point if it increased it): age < or = 48 years = 0 points, >48 years = 1 point; BMI < or = 32 = 1 point or >32 = 0 points for lumbar spine and Ward's triangle (WT); BMI < or = 30 = 1 point or >30 = 0 points for femoral neck (FN); TM < or = 5 years = 0 points or >5 years = 1 point. In all cases, bone absorptiometry (DEXA) was done. Comparison between groups was determined by Student's t test. Regression models were used to establish possible associations between bone absorptiometry and the clinical variables studied. Univariate and multivariate analyses were performed. RESULTS:The most highly significant differences were observed starting from 2 points in lumbar spine and FN. The most important difference in WT was detected starting from 1 point. In L1-L4 average, a significant correlation was established between the CI and age, TM, and BMI (r = 0.707; P < .001), as well as between the CI and the T score (r = 0.302; P < .001). FN analysis showed a correlation between the CI, the TM, and BMI (r = 0.720; P < .001) and between the CI and T score (r = 0.338; P < .001). WT analysis revealed a correlation between the CI and TM, and BMI (r = 0.698; P < .001) and between the CI and T score (r = 0.324; P < .001). CONCLUSION:It is reasonable to conclude that a score of 2 points in the lumbar spine and FN, and 1 point in WT, suggests the need for bone absorptiometry.
OBJECTIVE:To determine risk factors for osteoporosis in postmenopausal women from Mexico City. METHOD:The following prognostic variables for low bone density were analyzed in 400 postmenopausal women: age, body mass index (BMI), time since menopause (TM), previous and current hormone replacement therapy (HRT), previous use of corticosteroids, thyroid disease, and previous fractures. All patients were submitted to bone absorptiometry (DEXA) considering the diagnostic criteria for osteoporosis established by the WHO. All variables were analyzed in a bivariate mode, and logistic regression analysis was performed for variables that proved significant (age, TM, and BMI), estimating odds ratios and 95% confidence intervals. RESULTS:Age, TM and BMI resulted as significant risk factors for osteoporosis (P < .01), with the following cut-off points: age < or = 48 and >48 years; TM < or = 5 and >5 years; and BMI < or = 32 and >32 for L1-L4 average, BMI < or = 30 and >30 for femoral neck (FN), < or = 27 and >27 for trochanter, and < or = 32 and >32 for Ward's triangle (WT). Odds ratio (OR) for age was 1.57 at L1-L4 average (95% CI 1.01-2.47); OR for TM was 2.09 at L1-L4 average (95% CI 1.24-3.55), 2.05 at FN (95% CI 1.23-3.47) and 1.78 in WT (95% CI 1.05-2.99). OR for BMI was 0.36 at L1-L4 average (95% CI 0.17-0.80), 0.25 at FN (95% CI 0.12-0.5), 0.18 at trochanter (95% CI 0.10-0.32) and 0.29 at WT (95% CI 0.13-0.63). CONCLUSIONS:The various risk factors exerted different influences on the bone areas analyzed. Age increased the risk for lumbar spine osteoporosis, TM had a deleterious effect, while BMI showed a beneficial effect on bone density. These factors should be considered to establish the risk of osteoporosis in postmenopausal women, and to decide which patients should be submitted to absorptiometry.
: The aim of this study was to generate standard curves for normal spinal and femoral neck bone mineral density (BMD) in Mexican women using dual-energy X-ray absorptiometry (DXA), to analyze geographic differences and to compare these with “Hispanic” reference data to determine its applicability. This was a cross-sectional study of 4460 urban, clinically normal, Mexican women, aged 20–90 years, from 10 different cities in Mexico (5 in the north, 4 in the center and 1 in the southeast) with densitometry centers. Women with suspected medical conditions or who had used drugs affecting bone metabolism, were excluded. Lumbar spine BMD was significantly higher (1.089 ± 0.18 g/cm 2 ) in women from the northern part of Mexico, with intermediate values in the center (1.065 ± 0.17 g/cm 2 ) and lower values (1.013 ± 0.19 g/cm 2 ) in the southeast ( p <0.0001). Similarly, femoral neck BMD was significantly higher in women from the north (0.895 ± 0.14 g/cm 2 ), intermediate in the center (0.864 ± 0.14 g/cm 2 ) and lower (0.844 ± 0.14 g/cm 2 ) in the southeast part of Mexico ( p <0.0001). Northern Mexican women tend to be taller and heavier than women from the center and, even more, than those from the southeast of Mexico ( p <0.0001). However, these differences in BMD remained significant after adjustment for weight ( p <0.0001). A significant loss ( p <0.0001) in BMD was observed from 40 to 69 years of age at the lumbar spine and up to the eighth decade at the femoral neck. Higher and lower lumbar spine values, as compared with the “Hispanic” population, were observed in Mexican mestizo women from the northern and southeastern regions, respectively. In conclusion, there are geographic differences in weight and height of Mexican women, and in BMD despite adjustment for weight.